Thoraflex Hybrid and Relay Extension Post-Approval Study
A legfontosabb adatok
- Hol
- Aurora, Austin, Baltimore, Birmingham, Boston, Chicago, Durham, Hartford, Houston, Indianapolis, Los Angeles, New York, Philadelphia, Pittsburgh, Salt Lake City, St Louis és Washington D.C. (Egyesült Államok)Mind a 18 helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of ColoradoAurora, Egyesült ÁllamokNo longer taking part
- UT Dell Medical / Ascension Texas CardiovascularAustin, Egyesült ÁllamokNo longer taking part
- University of MarylandBaltimore, Egyesült ÁllamokNo longer taking part
- University of Alabama in Birmingham Medical CenterBirmingham, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- Northwestern UniversityChicago, Egyesült ÁllamokNo longer taking part
- Duke University Medical CentreDurham, Egyesült ÁllamokNo longer taking part
- Hartford HospitalHartford, Egyesült ÁllamokNo longer taking part
- Baylor College of Medicine - St. Luke'sHouston, Egyesült ÁllamokNo longer taking part
- Ascension St. Vincent Heart CenterIndianapolis, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai Medical CentreLos Angeles, Egyesült ÁllamokNo longer taking part
- Keck Medical Centre of USCLos Angeles, Egyesült ÁllamokNo longer taking part
- Weill Cornell MedicineNew York, Egyesült ÁllamokNo longer taking part
- University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- UPMC PresbyterianPittsburgh, Egyesült ÁllamokNo longer taking part
- University of UtahSalt Lake City, Egyesült ÁllamokNo longer taking part
- Washington University (Barnes-Jewish Hospital)St Louis, Egyesült ÁllamokNo longer taking part
- Medstar Washington Hospital CentreWashington D.C., Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Vascutek Ltd.
- Azonosító
- NCT05639400
- A regiszteradat frissítve
- 2026. február 6.
- Eredeti leírás
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.A teljes eredeti leírásKevesebb
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.
Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.
Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
Bevonási feltételek: Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study; Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.
Kizáró feltételek: Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.